ClinicalTrials.gov Compliance Will Improve, PhRMA Tells Rep. Waxman
Executive Summary
Industry may need several years to come into complete compliance with ClinicalTrials.gov, the Pharmaceutical Research & Manufacturers of America indicated in a letter to Rep. Henry Waxman (D-Calif.)
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PhRMA and ClinicalTrials.gov
Industry compliance with the ClinicalTrials.gov database was discussed at a July 15 board meeting of the Pharmaceutical Research & Manufacturers of America. "The heads of regulatory affairs at PhRMA member companies have said they believe they are in compliance" with ClinicalTrials.gov posting requirements. Data cited by Rep. Henry Waxman (D-Calif.) during a recent congressional hearing do not reflect the current rate of compliance, PhRMA said (1"The Pink Sheet" July 12, 2004, p. 4). The association believes a "fairer evaluation would look at what our companies submitted in 2003 and so far this year"...
PhRMA and ClinicalTrials.gov
Industry compliance with the ClinicalTrials.gov database was discussed at a July 15 board meeting of the Pharmaceutical Research & Manufacturers of America. "The heads of regulatory affairs at PhRMA member companies have said they believe they are in compliance" with ClinicalTrials.gov posting requirements. Data cited by Rep. Henry Waxman (D-Calif.) during a recent congressional hearing do not reflect the current rate of compliance, PhRMA said (1"The Pink Sheet" July 12, 2004, p. 4). The association believes a "fairer evaluation would look at what our companies submitted in 2003 and so far this year"...
FDA Unlikely To Act Unilaterally To Increase ClinicalTrials.gov Postings
FDA believes it has the authority to independently post clinical study information on ClinicalTrials.gov, but does not plan to create a systematic process for increasing the number of industry-sponsored trials listed on the site